C4 Therapeutics Announces 2024 Priorities and Extended Cash Runway to Advance Portfolio of Targeted Protein Degradation Medicines
09 Gennaio 2024 - 10:01PM
C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage
biopharmaceutical company dedicated to advancing targeted protein
degradation science, today announced 2024 priorities to execute
against its strategic plan to leverage the benefits of targeted
protein degradation across drug discovery and clinical development
to create and deliver breakthrough therapies for patients. These
priorities capitalize upon recent clinical data and key decisions,
resulting in a sharpened focus on executing high-potential programs
to ensure achievement of near-term milestones that position C4T for
future success.
Key 2024 priorities include advancing the CFT7455 and CFT1946
clinical programs to value-inflection milestones, supporting
CFT8919 Phase 1 development in China by partner Betta
Pharmaceuticals, delivering on three discovery collaborations and
progressing a streamlined internal discovery effort. As a result of
this prioritized portfolio, C4T is restructuring its operations and
reducing its workforce by approximately 30%.
C4T has strengthened its balance sheet to ensure sufficient
runway to execute through and beyond critical value-inflecting
clinical and discovery milestones. C4T has recently received
additional capital of approximately $107 million comprised of the
previously announced $25 million equity investment from a
subsidiary of Betta Pharmaceuticals, the $10 million upfront
payment from collaborator Merck for the Degrader-Antibody Conjugate
(DAC) collaboration and approximately $72 million in net proceeds
generated by leveraging the company’s at-the-market (or ATM)
facility. During the fourth quarter of 2023, C4T sold approximately
13.7 million shares under the ATM, at an average price of $5.42 per
share, resulting in $72 million of new equity capital, net of
commissions and fees.
“Building on recent momentum, we are well positioned to make
meaningful advances across our portfolio in 2024. Data from the
CFT7455 Phase 1 trial highlighted that the schedule adjustment is
yielding expected results, including IMWG responses, and we remain
focused on advancing the program to unlock its potential. In
addition, we are encouraged by the early pharmacokinetic and
pharmacodynamic data from the CFT1946 Phase 1 dose escalation,
which confirms oral bioavailability and dose proportional exposure
increases, which are associated with deep BRAF degradation,” said
Andrew Hirsch, president and chief executive officer of C4
Therapeutics. “Our sharpened focus on progressing CFT7455 and
CFT1946 to critical clinical milestones, along with advancing
targeted protein degradation research through our discovery
collaborations with Roche, Biogen and Merck and our internal
research efforts, will help C4T deliver breakthrough therapies for
patients with cancer and other diseases. Our strengthened balance
sheet, coupled with cost savings from our restructuring, provide
sufficient runway to execute through and beyond critical milestones
across the portfolio.”
Mr. Hirsch continued, “While we believe we are making
mission-driven decisions to prioritize our portfolio, restructuring
our company and impacting talented colleagues was not a decision we
made lightly. We are grateful for their contributions to C4T and
are treating our departing colleagues with compassion and
support.”
2024 ANTICIPATED MILESTONESThe
company announced the following key milestones for 2024:
CFT7455
- Present updated data from the ongoing Phase 1 dose escalation
trial in relapsed/refractory multiple myeloma (R/R MM) in 2H
2024
- Present data from the ongoing Phase 1 dose escalation trial in
relapsed/refractory non-Hodgkin’s lymphomas (R/R NHL) in 2H
2024
- Complete Phase 1 dose exploration in R/R MM and NHL by year-end
2024
CFT1946
- Present preclinical data demonstrating differentiated activity
in preclinical models of BRAF V600X melanoma, colorectal cancer,
non-small cell lung cancer and brain metastasis in 1H 2024
- Present data from the ongoing Phase 1 dose escalation trial in
melanoma, colorectal cancer, non-small cell lung cancer and other
cancers with BRAF V600X mutations in 2H 2024
CFT8919
- Support study start-up activities related to the Phase 1 dose
escalation trial in EGFR L858R mutated non-small cell lung cancer
by partner Betta Pharmaceuticals
RECENT ACHIEVEMENTS
CFT7455
- In December 2023, presented positive clinical data from the
ongoing CFT7455 Phase 1/2 trial in R/R MM. The data demonstrated
anti-myeloma activity, including International Myeloma Working
Group (IMWG) responses in patients who have undergone numerous
lines of prior therapy for multiple myeloma, including BCMA
therapies.
CFT1946
- Pharmacokinetic (PK) and pharmacodynamic (PD) data from the
initial escalation cohorts of the ongoing CFT1946 Phase 1/2 trial
in BRAF V600X mutant solid tumors demonstrate dose proportional
exposure and oral bioavailability, which are associated with deep
BRAF degradation.
PartnershipsBetta Pharmaceuticals
- In January 2024, the previously announced $25 million stock
purchase by a subsidiary of partner Betta Pharmaceuticals was
completed.
- In December 2023, partner Betta Pharmaceuticals received
approval from the Chinese National Medical Products Administration
for the Investigational New Drug application for CFT8919.
Merck
- In December 2023, C4T and Merck entered into a license and
research collaboration to discover and develop DACs. Under the
terms of the agreement, C4T and Merck will collaborate to develop
DACs directed to an initial undisclosed oncology target exclusive
to the collaboration; in January 2024, C4T received the $10 million
upfront payment for this initial target. C4T is eligible to receive
milestone payments totaling approximately $600 million, as well as
tiered royalties on future sales, for DACs directed to this initial
target.
FINANCIAL GUIDANCEUnaudited cash, cash
equivalents and marketable securities as of January 5, 2024 were
approximately $330 million. The company expects that its cash, cash
equivalents and marketable securities as of January 5, 2024,
together with anticipated cost savings from the restructuring, will
enable the company to fund its operating plan into 2027.
J.P. MORGAN PRESENTATIONC4T will present at the
42nd Annual J.P. Morgan Healthcare Conference on Thursday,
January 11, 2024 at 9:00 am PST (12:00 pm EST). A live webcast will
be available under “Events & Presentations” in the Investors
section of the company’s website at www.c4therapeutics.com. A
replay of the webcast will be archived on the C4T website for at
least two weeks following the presentation.
About C4 TherapeuticsC4 Therapeutics (C4T)
(Nasdaq: CCCC) is a clinical-stage biopharmaceutical company
dedicated to delivering on the promise of targeted protein
degradation science to create a new generation of medicines that
transforms patients’ lives. C4T is progressing targeted oncology
programs through clinical studies and leveraging its
TORPEDO® platform to efficiently design and optimize
small-molecule medicines to address difficult-to-treat diseases.
C4T’s degrader medicines are designed to harness the body’s natural
protein recycling system to rapidly degrade disease-causing
proteins, offering the potential to overcome drug resistance, drug
undruggable targets and improve patient outcomes. For more
information, please visit www.c4therapeutics.com.
About CFT7455CFT7455 is an orally bioavailable
MonoDAC™ degrader designed to be highly potent and selective
against its intended targets of Ikaros (IKZF1) and Aiolos (IKZF3)
and overcome shortcomings of currently approved therapies to treat
multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). CFT7455 is
currently in a Phase 1 dose escalation study in MM and NHL. Initial
clinical data show CFT7455 is well tolerated, demonstrates
anti-myeloma activity and displays evidence of immunomodulatory
effects. More information about this trial may be accessed at
www.clinicaltrials.gov (identifier: NCT04756726).
About CFT1946CFT1946 is an orally bioavailable
BiDAC™ degrader designed to be potent and selective against BRAF
V600X mutant targets. In preclinical studies, CFT1946 is
active in vivo and in vitro in models with BRAF
V600E-driven disease and in models resistant to BRAF inhibitors.
CFT1946 is currently in a Phase 1 dose escalation study in BRAF
V600 mutant solid tumors including non-small cell lung cancer,
colorectal cancer and melanoma. More information about this trial
may be accessed at www.clinicaltrials.gov (identifier:
NCT05668585).
About CFT8919CFT8919 is an orally bioavailable
allosteric BiDAC™ degrader that is designed to be potent and
selective against EGFR bearing an oncogenic L858R mutation. In
preclinical studies, CFT8919 is active in in
vitro and in vivo models of L858R driven non-small
cell lung cancer. Importantly, in preclinical studies, CFT8919
retains full activity against additional EGFR mutations that confer
resistance against approved EGFR inhibitors including L858R-C797S,
L858R-T790M and L858R-T790M-C797S. In 2023, C4T and Betta
Pharmaceuticals entered into an exclusive licensing and
collaboration agreement for the development and commercialization
of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and
Taiwan.
Forward-Looking StatementsThis press release
contains “forward-looking statements” of C4 Therapeutics, Inc.
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements may include, but may not
be limited to, express or implied statements regarding our ability
to develop potential therapies for patients; the design and
potential efficacy of our therapeutic approaches; the predictive
capability of our TORPEDO® platform in the development of
novel, selective, orally bioavailable BiDAC™ and MonoDAC™
degraders; the potential timing, design and advancement of our
preclinical studies and clinical trials, including the potential
timing for and receipt of regulatory authorization related to
clinical trials and other clinical development activities including
clinical trial commencement; our ability and the potential to
successfully manufacture and supply our product candidates for
clinical trials; our ability to replicate results achieved in our
preclinical studies or clinical trials in any future studies or
trials; our ability to replicate interim or early-stage results
from our clinical trials in the results obtained when those
clinical trials are completed or when those therapies complete
later stage clinical trials; regulatory developments in the United
States and foreign countries; the potential timing for updates on
our clinical and research programs; and our ability to fund our
future operations. Any forward-looking statements in this press
release are based on management’s current expectations and beliefs
of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to: uncertainties related to the initiation,
timing, advancement and conduct of preclinical and clinical studies
and other development requirements for our product candidates; the
risk that any one or more of our product candidates will cost more
to develop or may not be successfully developed and commercialized;
and the risk that the results of preclinical studies and/or
clinical trials will or will not be predictive of results in
connection with future studies or trials. For a discussion of these
and other risks and uncertainties, and other important factors, any
of which could cause our actual results to differ from those
contained in the forward-looking statements, see the section
entitled “Risk Factors” in C4 Therapeutics’ most recent Annual
Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed
with the Securities and Exchange Commission. All information in
this press release is as of the date of the release and C4
Therapeutics undertakes no duty to update this information unless
required by law.
Contacts:Investors: Courtney SolbergSenior
Manager, Investor RelationsCSolberg@c4therapeutics.com
Media: Loraine Spreen Senior Director, Corporate
Communications & Patient
Advocacy LSpreen@c4therapeutics.com
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